Compression bandage system

ABSTRACT

A compression bandaging system comprising a) an inner skin facing, elongated, elastic bandage comprising: (i) an elongated, elastic substrate and (ii) an elongated layer of foam, said foam layer being affixed to a face of said substrate and extending 33% or more across said face of substrate in transverse direction and 67% or more across said face of substrate in longitudinal direction; and b) an outer, elongated, self-adhering elastic bandage; said bandage having a compressive force when extended; wherein, in use, said foam layer of the inner bandage faces the skin and the outer bandage overlies the inner bandage.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to European Patent Application No.05007775.9, filed Apr. 8, 2005.

This invention relates to compression bandage systems, in particular forthe use in the treatment and/or management of venous leg ulceration.

BACKGROUND

Compression bandages are known for use in the treatment of oedema andother venous and lymphatic disorders, e.g., of the lower limbs. An areawhere compression bandages are considered particularly useful is in themanagement and treatment of chronic wounds, such as venous leg ulcers.

The mainstay in nearly all venous leg ulcer treatments is theapplication of a 3 to 4 layer compression bandage, whereby the conceptof such multi-layer bandaging is the use of a combination of differenttypes of bandage layers in order to apply pressure in layers (giving anaccumulation of pressure) and to provide sustained compression togetherwith rigidity. A common, widely used bandage is a four-layer systemincluding an inner layer of absorbent orthopedic wool, a second layercrepe bandage, a third layer of light compression bandage and a fourthlayer of self-adherent (cohesive) flexible bandage. Such a bandagingsystem has been described in “The Function of Multiple Layer CompressionBandaging in the Management of Venous Ulcers,” DDI Wright et al, SWM,10, 109.10, 1988, and is, e.g., commercially available under the tradedesignation “PROFORE”. Although such 3 to 4 layer bandaging systemsprovide sufficient pressure for therapeutic treatment and/or managementof chronic wounds such as venous leg ulcers, the process of applyingsuch bandages, however, is difficult (for example to obtain the desiredpressure and/or a relatively uniform pressure) as well as timeconsuming. Also such bandages are prone to slipping and/or formingwrinkles after being applied which may result in insufficient and/oruneven compression being applied and/or cause discomfort to the patient.

Although other compression bandage systems (such as those disclosed inU.S. Pat. No. 6,759,566 and US 2002/0099318) have been proposed inattempts to provide bandaging systems that are easier to apply, inparticular by inexperienced staff, such systems often do not provide thedesired therapeutic compressive pressure or are not capable ofmaintaining the desired therapeutic compressive pressure for extendedperiods of time. Furthermore, such systems typically still have atendency (and in some cases an increased tendency) to slip and/orwrinkle after application.

SUMMARY OF THE INVENTION

Surprisingly, it has been found that through the provision of acompression bandaging system comprising: (a) an inner skin-facing,elongated, elastic bandage comprising an elongated, elastic substrateand an elongated layer of foam, said foam layer being affixed to a faceof the substrate and extending 33% or more across the face of substratein transverse direction and 67% or more in longitudinal direction; and(b) an outer, elongated, self-adhering elastic bandage which has acompressive force when extended, it is possible to provide a compressionbandage system which is easy to apply and provides desired therapeuticeffect for extended periods of time.

In some embodiments, in use, the compression bandaging system comprises:a) an inner skin facing, elongated, elastic bandage having inner andouter faces and comprising: (i) an elongated, elastic substrate havingfirst and second faces, the second face comprising a self-adheringmaterial, and (ii) an elongated layer of foam, said foam layer beingaffixed to the first face of said substrate and extending 33% or moreacross said first face of substrate in transverse direction and 67% ormore across said first face of substrate in longitudinal direction, thefoam layer having an exposed face not affixed to the first face of saidsubstrate and not comprising a self-adhering material, the inner face ofthe inner bandage comprising the exposed face of the foam layer, and theouter face of the inner bandage comprising the second face of theelongated, elastic substrate; and b) an outer, elongated, self-adheringelastic bandage; said bandage having a compressive force when extended;wherein, in use, said outer bandage overlies the inner bandage, and saidinner face of the inner bandage faces the skin, and the outer face ofthe inner bandage faces said outer bandage, wherein the inner and outerbandages are configured and adapted such that in use said bandagesremain adhered to one another under elastic extension without the use ofa fastening mechanism, and wherein the bandaging system is free of anyadditional elongated bandages.

In some embodiments, in use, the compression bandaging system comprises:a) an inner skin facing, elongated, elastic bandage comprising: (i) anelongated, elastic substrate, and (ii) an elongated layer of foam, saidfoam layer being affixed to a face of said substrate and extending 33%or more across said face of substrate in transverse direction and 67% ormore across said face of substrate in longitudinal direction; and b) anouter, elongated, self-adhering elastic bandage; said bandage having acompressive force when extended; wherein, in use, said foam layer of theinner bandage faces the skin and the outer bandage overlies the innerbandage, wherein the inner and outer bandages are configured and adaptedsuch that in use said bandages remain adhered to one another underelastic extension without the use of a fastening mechanism, wherein thebandaging system is free of any additional elongated bandages, andwherein the elongated, elastic substrate of the inner bandage, whenextended, provides less compression than the outer bandage whenextended.

In some embodiments, in use, the compression bandaging system comprises:a) an inner skin facing, elongated, elastic bandage having inner andouter faces and comprising: (i) an elongated, elastic substrate havingfirst and second faces, the second face comprising a self-adheringmaterial, and (ii) an elongated layer of foam, said foam layer beingaffixed to the first face of said substrate and extending 33% or moreacross said first face of substrate in transverse direction and 67% ormore across said first face of substrate in longitudinal direction, thefoam layer having an exposed face not affixed to the first face of saidsubstrate and not comprising a self-adhering material, the inner face ofthe inner bandage comprising the exposed face of the foam layer, and theouter face of the inner bandage comprising the second face of theelongated, elastic substrate; and b) an outer, elongated, self-adheringelastic bandage; said bandage having a compressive force when extended;wherein, in use, said outer bandage overlies the inner bandage, and saidinner face of the inner bandage faces the skin, and the outer face ofthe inner bandage faces said outer bandage, wherein the inner and outerbandages are configured and adapted such that in use said bandagesremain adhered to one another under elastic extension without the use ofa fastening mechanism, and wherein the bandaging system is free of anyadditional elongated bandages, and the inner bandage when extendedprovides less compression than the outer bandage when extended.

The term “elongated bandage” as used herein is generally understood tomean that the bandage is sufficiently elongated so as to be capable ofbeing wound 2 turns or more (more suitably 5 turns or more) about a limbof a patient.

In use, the foam layer of the inner bandage faces the skin with theouter bandage overlaying the inner bandage. It has been found that dueto the elasticity of the inner bandage substrate as well as advantageousinterfacing between it and the outer bandage upon application, theskin-facing foam layer, in particular the exposed face of the foam layerfacing directly towards the skin of the patient, demonstrates aparticularly desirable and effective fastening onto the skin of thepatient, which minimizes of tendency of the bandage system towardsslippage after application.

It has been found preferable to provide an outer, elastic, compressionbandage having a stretch capability in the longitudinal direction of notmore than 75% (more preferably not more than 65%, most preferably notmore than 55%). With such outer compression bandages, it is relativelyeasy, in particular for inexperienced staff, to apply the bandage at thedesired therapeutic pressure, for example by applying the outer bandageat or close to full extension. Furthermore, it was found that the use ofouter bandages having such limited extensibility aids in providingdesirably low resting pressures and yet at the same time high walkingpressures of the applied bandage system.

For yet further ease in application and avoidance of formation ofwrinkling of the inner skin facing bandage during application of thebandage, it has been found preferably to provide an inner bandage havinga stretch capability of less than 75% (more preferably less than 65%,most preferably less than 50%) in the longitudinal direction.

It also has been found particularly advantageous to configure and adaptthe outer bandage and the inner bandage, such that in use the inner andouter bandages remain adhered to one another under elastic extension,e.g., without the use of a fastening mechanism. With such preferredembodiments, after application, the outer and inner bandages inprinciple act as a single bandaging entity—minimizing, if noteliminating, any potential of slippage and/or wrinkling between the twobandaging layers, and thus facilitating comfort for the patient as wellas overall conformability of the complete, applied bandaging system anduniformity of compressive pressure over extended periods of time.

Advantageously, bandaging systems described herein allow the provisionof effective and sustained therapeutic performance without applicationof any additional elongated bandages besides the herein described innerand outer bandages.

Bandaging systems described herein may optionally include a wounddressing or plaster for covering and thus protecting an open wound, suchas an ulcer, under the applied bandaging system. Such dressings orplasters are typically appropriately sized to offer protection for thewound and immediate-surrounding skin about the wound. Such wounddressings or plaster are typically non-elongated. The term“non-elongated dressing or plaster” as used herein is generallyunderstood to mean that the dressing or plaster is not sufficientlyelongated so as to be capable of being wound two turns about a limb of apatient. Preferably a non-elongated dressing or plaster is sized suchthat it can only be wound at most one turn about a limb of a patient,more preferably sized such it cannot be wound one turn about a limb of apatient.

Bandaging systems described herein are advantageously provided in theform of a kit-of-parts.

Bandaging systems described herein are particularly adapted for use inthe treatment and/or management of oedema and other venous and lymphaticdisorders of a limb, more particularly venous leg ulcers and lymphoedemaof a limb.

In methods of using compression bandaging systems described herein, theinner bandage is applied, e.g., by spirally winding the bandage about alimb of a patient, with the foam layer facing the skin of the patient,and subsequently the outer bandage is applied, e.g., again by spirallywinding the bandage, over the inner bandage. If desired or needed, priorto the application of the inner bandage, a wound dressing or plaster maybe applied to a wound or wounds.

The dependent claims define further embodiments of the invention.

It is to be understood that the present invention covers allcombinations of particular, suitable, desirable, favorable advantageousand preferred aspects of the invention described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary embodiment of the inner skin-facingbandage.

FIG. 2 illustrates an exemplary embodiment of the outer elastomericbandage.

FIGS. 3 a-3 e and 4 illustrate exemplary embodiments of using thecompression bandaging system.

DETAILED DESCRIPTION

Compression bandaging systems in accordance with the present inventioninclude an inner skin facing, elongated, elastic bandage 10 (asexemplified in FIG. 1 and described in detail below) and an outer,elongated, self-adhering, elastic compression bandage 20 (as exemplifiedin FIG. 2 and described in detail below). Each bandage is sufficientlyelongated so as to be capable of being wound 2 or more turns (moresuitably 5 or more turns) about a limb of a patient, as exemplified inFIG. 3. The particular, appropriate dimensions of the bandages depend inpart on the particular limb being treated and/or the particular patient.For example, in human (adult) therapy for use with lower limbs, suitabledimensions for the bandages may be about 70 to about 130mm wide andabout 2 to about 4.5 m long, while for use with upper limbs a width ofabout 70 to about 130 mm is suitable with a corresponding shorter lengththan that use for lower limbs. For applications in veterinary medicine,depending on the particular animal patient, appropriate, suitabledimensions may be larger (e.g., for equine bandaging) or smaller (e.g.,for canine bandaging).

Each bandage is desirably, sufficiently porous to allow for transmissionof air and moisture vapor through the bandage (e.g., a water vaportransmission rate (WVTR) of at least 240 g/m²/24 h, more suitably of atleast 400 g/m²/24 h, e.g., as determined by ASTM E398-03 at 37.8° C. and100% relative humidity in the wet chamber and 37.8° C. and 10% relativehumidity in the dry chamber). In addition, each bandage, in particularthe inner skin-facing bandage, may be sterilized, e.g., gammasterilized.

Referring to FIG. 2, the outer, elongated, self-adhering elastic bandage20 of compression bandaging systems described herein is adapted toprovide a compressive force, more particularly a permanent compressiveforce, when extended. In use, preferred outer bandages will provide asub-bandage, resting compressive force of from about 1 to about 80 mm Hg(more suitably from about 20 to about 75 mmHg, most suitably from about30 to about 70 mmHg) at a position 8 cm above the medial malleolus, whenwrapped about a human adult leg with an ankle circumference of 22 cm. Asuitable method to measure compressive force is described below in thetest protocol—Sub-bandage Pressure Measurement Procedure—which is basedon the method reported in Melhuish et al, Phlebology, 15: 53-59 (2000).

As mentioned above, for ease in application and aiding in providingdesirable low resting pressures and high walking pressures, it has beenfound particularly advantageous to provide outer elastic, compressionbandages having a limited, relatively low extensibility in itslongitudinal direction, in particular having a stretch capability in thelongitudinal direction of not more than 75%, more preferably not morethan 65%, most preferably not more than 55%, e.g., as determined inaccordance with the Stretch Testing Procedure summarized below. Withinthis range a minimal stretch capability of at least 20% in thelongitudinal direction is desirable, at least 25% more desirable, and atleast 30% most desirable. To ensure favorable conformability andretention of compressive recovery of the bandage through the time periodthe bandage is in place, the outer bandage desirably shows highelasticity in its longitudinal direction, in particular arecovery-of-stretch capability of at least 85%, more desirably at least90%, most desirably at least 95%, in the longitudinal direction, e.g.,as determined in accordance with the Stretch Testing Proceduresummarized below.

Preferred outer bandages do not adhere to clothing, hair or skin.

Preferred outer bandages are self-adhering elastomeric bandages, morepreferably self-adherent elastomeric bandages, which do not adhere toclothing, hair or skin.

Examples of suitable types of self-adherent elastomeric bandages as wellas methods of making such bandages are disclosed in U.S. Pat. Nos.3,575,782; 4,984,584; and US Application 2005/0025937A, the contents ofwhich are incorporated in their entirety herein by reference. Examplesof other suitable types of self-adherent elastomeric bandages aredisclosed in U.S. Pat. No. 6,156,424, the content of which isincorporated in its entirety herein by reference. Other example ofsuitable types of self-adherent bandages include knitted and wovenbandages commercially available under the trade designations ROSIDALHAFT (Lohman & Rauscher GmbH & Co. KG, Neuwied Germany) and ACTICO(Activa Health Care, Burton-upon-Trent, UK).

As shown in FIG. 2, outer bandages 20 may suitably comprise a woven,knitted or nonwoven bandage comprising generally a plurality ofgenerally longitudinally extending elastic yarns in the woven, knittedor nonwoven structure 22, said bandage being coated or impregnated witha polymer binder. More suitably outer bandages may comprise a pluralityof generally longitudinally extending, (preferably partially extended)elastic yarns bound with a polymeric binder between two webs or boundwith a polymeric binder on a web. Favorably the polymeric binder iscohesive, so that the bandage is self-adherent (i.e. in use the bandagewill remain adhered to itself under elastic extension e.g., without theuse of a fastening mechanism), but will not adhere to clothing, hair orskin. Accordingly, generally the top and bottom faces of the bandagecomprise polymeric binder, e.g., where the polymeric binder generallyextends throughout the thickness of the bandage.

Suitable polymeric binders providing cohesive properties may be eitherelastomeric or non-elastomeric polymeric binders, however, preferablythe polymeric binder is an elastomeric polymeric binder due to generallyfavorable properties of such binders, such as long-term flexibility,extensibility and/or elasticity. Suitable elastomeric polymeric bindersmay comprise natural rubber latex, a synthetic latex, such ashomopolymer and copolymer latexes of acrylics, butadienes,styrene/butadiene rubbers, chloroprenes, ethylenes (e.g., vinylacetate/ethylene), isoprenes, nitriles and urethanes, or mixturesthereof. Examples of suitable polymeric elastomeric binders aredisclosed for example in U.S. Pat. Nos. 3,575,782; 4,984,585; and6,156,424 as well as in textbooks, such as Neoprene Latex: Principles ofCompounding and Processing, J. C. Carl, 1962, Delaware, E. I: DuPont deNemours (e.g., under the section entitled Contact Bond Adhesives, onpage 100) and Handbook of Adhesives 3^(rd) Edition, Ed. I. Skeist, 1990,New York, Van Nostrand Reinhold (e.g., page 305). Outer bandages may bedesirably free of natural rubber latex.

For configurations including elastic yarns bound on a web or betweenwebs, suitable webs include woven, knitted, warp-knit, or nonwovenfibrous webs, woven and nonwoven fibrous webs being more suitable, andnonwoven fibrous webs most suitable in terms of providing a favorablythin outer compression bandage, especially in its extended state. Asmentioned above, preferably elastic yarns are partially extended (e.g.,being maintained under partial tension) within the bandage. In order toprovide preferred limited extensibility in the longitudinal direction asdescribed above, during the manufacturing of such bandages (e.g., duringbinding of elastic yarns with polymeric binder between said webs or on aweb) it is preferable to stretch the yarns to a length of at most 2.0,more preferably at most 1.75, even more preferable at most 1.5, mostpreferably about 1.5 times their fully relaxed length. The ratio ofstretched length to relaxed length of yarn is referred to as draw ratio.Generally a draw ratio of at least 1.2 to 1 is desirable. Extent ofcompression provided is generally related to, inter alia, size of theelastic yarns and the number of yarns, whereby increased compression istypically a result of using greater number of larger elastic yarns inthe bandage. Suitably, the number of elastic yarns per inch (epi) mayrange from about 8 to about 25 epi, while the elastic yarns may have adenier ranging from about 280 to about 1700. For use in bandagingsystems for treatment and/or management of venous leg ulceration, it hasbeen found that the use of from about 10 to about 20 epi together with aelastic yarn denier of about 650 or less (more favorably about 620 orless, most favorably about 580 or less) in outer bandages is beneficialin providing desirable ease in handling of the outer bandage itself aswell as desired therapeutic compressive force without observation ofundesirable high resting pressures. Within the mentioned denier range, asuitable minimal denier for effective desired therapeutic compressiveforce may be at least about 350 denier (more favorably at least about425 denier, and most favorably at least about 500 denier).

As shown in FIG. 1, the inner, skin facing elongated, elastic bandage 10of compression bandaging systems described herein comprises anelongated, elastic substrate 16 and an elongated layer of foam 12, saidfoam layer 12 being affixed to a face of said substrate 16 and extending33% or more across the face of substrate 16 in transverse direction and67% or more across the face of substrate 16 in longitudinal direction.

As mentioned above, for enhanced ease in application and avoidance offormation of wrinkling of the inner skin facing bandage duringapplication of the bandage, it has been found preferably to provide aninner bandage having a stretch capability of less than 75% (morepreferably less than 65%, most preferably less than 50%) in thelongitudinal direction, e.g., as determined in accordance with theStretch Testing Procedure summarized below. Within this range a minimalstretch capability of at least 15% in the longitudinal direction isdesirable, at least 20% more desirable, and at least 25% most desirable.To ensure favorable conformability, the inner bandage desirably shows arecovery-of-stretch capability of at least 80%, more desirably at least85%, most desirably at least 90%, in the longitudinal direction, e.g.,as determined in accordance with the Stretch Testing Proceduresummarized below.

Also as mentioned above, it also has been found particularlyadvantageous to configure and adapt the outer bandage and the innerbandage (in particular at least the outer face of the inner bandage(e.g., the face of the inner bandage facing away from the skin andtowards the outer bandage in use)), such that in use the inner and outerbandages remain adhered to one another under elastic extension, e.g.,without the use of a fastening mechanism. Such configurations mayinclude an inner bandage, in particular its outer face, comprising thesame self-adherent material as the outer bandage or another appropriateself-adherent material, such that in use the inner and outer bandagesremained adhered to one another under elastic extension, e.g., withoutthe use a fastening mechanism.

Desirably the outer face of the inner bandage comprises a self-adheringmaterial, more desirably a self-adhering elastomeric material. The outerface of the inner bandage may be provided with such a self-adherentmaterial, for example by providing (e.g., affixing) an elongated layeror a web including such material onto the second face 18 of the elasticsubstrate, i.e. the face of the elastic substrate opposite of the face(i.e. the first face) to which the foam layer is affixed. However inconsideration of the provision of favorably thin inner bandages and thuswearing comfort for the patient, preferably the second face 18 of theelastic substrate 16 forms the outer face of the inner bandage as shownin FIG. 1. Accordingly, preferred embodiments of the inner bandagecomprise an elastic substrate, in particular an elastic substrate inwhich at least its second face 18, comprises a self-adhering material,more preferably a self-adhering elastomeric material.

The elastic substrate may favorably be made of a material (morefavorably a self-adhering material, more favorably a self-adheringelastomeric material), which is capable of exerting a compressive force(in particular a permanent compressive force) when extended. In suchpreferred embodiments, although the elastic substrate may suitably bemade of the same material as the outer bandage, it has been found moresuitable to provide a related compression material that it provides alesser amount of compression (than the outer bandage) when extended.

Elastic substrates may suitably comprise a woven, knitted or a nonwovenweb comprising generally a plurality of generally longitudinallyextending elastic yarns in the woven, knitted or nonwoven structure,said web being coated or impregnated with a polymer binder. Moresuitably elastic substrates of the inner bandage may comprise aplurality of generally longitudinally extending, partially extended ornon-extended elastic yarns bound with a polymeric binder between twowebs or bound with a polymeric binder on a web. Favorably the polymericbinder is cohesive, so that elastic substrate is self-adherent, but willnot adhere so clothing, hair or skin. Accordingly, at least the secondface and more suitably both faces of the elastic substrate comprisepolymeric binder (e.g., where the polymeric binder extends throughoutthe thickness of the web). Suitable polymeric binders include thosedescribed above in connection with outer bandages. Accordingly suitablepolymeric binders providing cohesive properties may be eitherelastomeric or non-elastomeric polymeric binders. Preferably thepolymeric binder is an elastomeric polymeric binder. Suitableelastomeric polymeric binders may comprise natural rubber latex, asynthetic latex, such as homopolymer and copolymer latexes of acrylics,butadienes, styrene/butadiene rubbers, chloroprenes, ethylenes (e.g.,vinyl acetate/ethylene), isoprenes, nitriles and urethanes, or mixturesthereof. Again examples of suitable polymeric elastomeric binders aredisclosed for example in U.S. Pat. Nos. 3,575,782; 4,984,585; and6,156,424 and in textbooks, such as those mentioned above. Innerbandages may be desirably free of natural rubber latex.

In embodiments of the inner bandage, in particular the elastic substratethereof, including any type of self-adhering material (as describedabove), it is preferred that the respective self-adhering material doesnot adhere to clothing, hair or skin.

For configurations including elastic yarns bound on a web or betweenwebs, suitable webs include woven, knitted, warp-knit, or nonwovenfibrous webs, woven and nonwoven fibrous webs being more suitable, andnonwoven fibrous webs most suitable in terms of providing a favorablythin elastic substrate, especially in its extended state. Partiallyextended yarns are preferred. During the manufacturing of such elasticsubstrates (e.g., during binding of elastic yarns with polymeric binderbetween said webs or on a web) it is preferable to stretch the yarns toa length of 5 times or less (more favorably 3.5 or less) times theirfully relaxed length. Generally a draw ratio of at least 1.2 to 1 isdesirable. Favorably the epi is less than 15, more favorably 12 or less,most favorably 10 epi or less. Within this range, an epi of 4 or more issuitable, 5 or more is more suitable, 6 or more is most suitable.Desirably elastic yarns have a denier less than 550, more desirably 450or less, most desirably about 350 or less. Within this range, a denierof 100 or more is suitable, 150 or more is more suitable, and 200 ormore is most suitable.

As shown in FIG. 1, the foam layer 12 is affixed to the first face ofthe elastic substrate. A variety of means are suitable for affixing thefoam layer 12 onto the elastic substrate 16 such as stitching, needletacking, ultrasonic welding or bonding, e.g., mechanical, thermal, andchemical bonding as well as combinations thereof. Suitable means ofchemical bonding include using an adhesive, for example in the form of acontinuous or discontinuous layer (e.g., a pattern-coated adhesivelayer). Suitable adhesives for use can be any of those useful for wounddressings, such as those disclosed in WO 99/27975; WO 99/28539; U.S Re.24,906; U.S. Pat. Nos. 5,849,325; and 4,871,812; the contents of whichare incorporated in their entirety herein by reference. Another suitablemeans of bonding includes providing the first face of the elasticsubstrate with a polymeric binder, in particular an elastomeric polymerbinder, having cohesive properties (as described above) and affixing thefoam to the first face of the elastic substrate by applying the foamunder pressure onto the substrate (e.g., passing the elongated foam andsubstrate through two driven rollers at a pressure around 0.3 M Pa),wherein a chemical and/or mechanical bond is provided between the foamand substrate. Alternatively the foam layer 12 may be affixed to thefirst face of the elastic substrate 16 by forming the foam directly ontothe elastic substrate 16. To ensure a relatively smooth, generallynon-wrinkled and/or non-puckered foam layer, preferably the foam layeris affixed to the elastic substrate, while the substrate is in agenerally non-extended (e.g., 10% or less of the substrate totalextensibility) state or a completely relaxed state.

Generally the foam layer 12 is suitably affixed to the elastic substrate16 beginning substantially at one transverse end of the substrate andextending 67% or more (more desirably 80% or more, more desirably 90% ormore, even more desirably 95%) across the length of substrate towardsthe second transverse end. The portion near the second transverse end ofthe elastic substrate may be not covered by the foam layer, for example,to provide a tab of elastic substrate alone at the very end of thebandage to allow one or two wraps of elastic substrate onto itselfHowever in preferred embodiments, as shown in FIG. 1, the foam layer 12is essentially coextensive or coextensive with the elastic substrate 16face in the longitudinal direction. That the foam layer is essentiallycoextensive or coextensive in the longitudinal direction is preferred,because during bandaging it is desired for therapeutic reasons and/orpatient comfort to have the person applying the bandage to simply cutoff any excess bandage in length, and it has been observed that if thebandage includes a tab at the end, very often the applier, feelingobliged to make use of the tab, will not cut off any excess length.

Also generally the foam layer 12 is suitably affixed to the elasticsubstrate 16 beginning substantially at one longitudinal edge of thesubstrate and extending 33% or more across the width of the substratetowards the second longitudinal end. The particular amount of extensionof the foam layer 12 across the width of the elastic substrate 16(transverse extension) depends in part on how the inner bandage isapplied. For example applications using a spiral winding of the innerbandage about a limb using standard 67% or 50% overlaps, a 33% and 50%transverse extension, respectively, may be suitable. Here for example asthe bandage is spirally wound about the limb, the exposed face 14 offoam layer 12 comes into contact with the skin and the portion of thefirst inner face (along the length) of elastic substrate, which is notcovered by the foam layer, comes into contact with the outer face of theinner bandage (from the previous turn). To further enhance ease inapplication and more importantly to facilitate uniformity of compressiveforce upon application of the bandage-system and the maintenance of auniform compressive force over time after application, it has been foundadvantageous to apply the inner bandage with an overlap of less than 50%(in particular with an overlap of 33% or less, more particular 20% orless, even more particular 10% or less, most particularly 5% or less).Accordingly the transverse extension of the foam layer is advantageously50% or more (in particular 67% or more, more particular 80% or more,even more particular 90% or more, yet even more particular 95% or more).In preferred embodiments as shown in FIG. 1, the foam layer 12 isessentially coextensive or coextensive with the first face of theelastic substrate in the transverse direction.

As used herein, the term “foam” refers to a polymeric materialcontaining open and/or closed cells dispersed throughout its mass,preferably polymeric foam containing open cells. Suitable foams for thefoam layer include flexible, resilient foams. Suitable foams include,but are not limited to, polyurethane, carboxylated butadiene-sytrenerubber, polyester, polyacrylate, polyether, and polyolefin foams, forexample, such as those described in U.S. Pat. Nos. 3,908,645 and6,548,727, the contents of which are incorporated in their entiretyherein by reference. Preferred foam materials are polyurethanes.

For certain therapeutic uses of compression bandaging systems, it may bedesirable that said systems, in particular foam layers thereof, absorbwound exudates. Thus foams used for the foam layers may advantageouslybe absorbent foams, e.g., absorbing greater than 250% aqueous salinesolution when immersed for 30 minutes in phosphate saline containing 0.9wt % NaCl at 37° C., e.g., in accordance with the Saline Absorbency Testoutlined below. Suitable open cell foams that allow transport of fluidand cellular debris into and within the foam, generally and desirablyhave an average cell size (typically, the longest dimension of a cell,such as the diameter) of at least about 30 microns, more desirably atleast about 50 microns, and desirably no greater than about 800 microns,more desirably no greater than about 500 microns, as measured byscanning electron microscopy (SEM) or light microscopy. Favorably to aidin preventing skin macerations, such foams may also be desirably,substantially non-swelling, e.g., increasing in volume by no greaterthan about 15% following a 30-minute soaking in phosphate salinecontaining 0.9 wt % NaCl at 37° C., e.g., in accordance with the SalineSwelling Test outlined below. However surprisingly it has been observedthat for foams showing higher swelling characteristics, e.g., greaterthan 15% (in particular up to 75%, more particular up to 55% and mostparticular up to 35%) in accordance with the Saline Swelling Test,during use in the compression of the foam layer, such foam of the foamlayer typically does not show any significant swelling or only a minimalamount of swelling due to compression forces of the bandaging systempushing and distributing absorbed fluid and cellular debris throughoutthe foam layer. This also holds true for foam layers made ofsubstantially non-swelling foams.

Suitable foams may be either hydrophilic or hydrophobic, more suitablythey may be hydrophobic and treated to render them more hydrophilic,e.g., with surfactants such as nonionic surfactants, such asoxypropylene-oxyethylene block copolymers.

As mentioned above, in use of bandaging systems described herein, theexposed face 14 of the foam layer 12 facing directly towards and cominginto the contact with the skin of the patient demonstrates aparticularly desirable and effective fastening onto the skin of thepatient, which facilitates the minimization of tendencies of the bandagesystem towards slippage after application. To allow for desirablecontouring of the foam layer to the particular limb of the patient andthus further enhanced, advantageous fastening of the foam onto the skin,the foam preferably has a thickness greater than 1.6 mm, more preferablygreater than 2 mm. Within this range, a thickness of 10 mm or less issuitable; 8 mm or less being more suitable, 6 mm or less even moresuitable, 5 mm or less yet even more suitable, 4 mm or less mostsuitable. To ensure such desirable fastening, the outer, exposed face 14of the foam layer 12 is typically substantially free of materials, e.g.,which could interfere with the foam-skin interface, being affixed tosaid face of the foam layer, such as fibers, nettings, and anti-adherentfilms. In some embodiments, the outer, exposed face 14 of the foam layer12 (the face not affixed to substrate 16) does not comprise aself-adhering material. In other words, the outer, exposed face 14 ofthe foam layer 12 typically forms the innermost skin-facing surface ofthe inner bandage, with the possible exception of any optional tabmaterial (typically having a width of 10% or less in the longitudinaldirection of the bandage) at one or both terminal transverse ends of thebandage.

Referring to FIGS. 3 a-3 e, in preferred methods of using bandagingsystems described herein, after any optional application of anon-elongated wound dressing or plaster to cover any open wound orwounds and the immediate skin area surrounding such wound(s), the innerbandage is applied with foam layer 12 facing towards and contacting theskin, typically in a spiral technique as exemplified in FIGS. 3 a-3 bwith an appropriate overlap as detailed above. Preferably the innerbandage 10 is applied using a minimal of tension or no tension. Ifnecessary or desired the inner bandage can be temporarily fixed, e.g.,at the end of the last wrap, using a piece of adhesive tape or anothertype of suitable fastener. Alternatively but less preferable, a tab ofadherent (preferably self adherent) material may be added on the innerskin-facing face and terminal end of the inner bandage in order toprovide a suitable, integral fastening means for temporarily fasteningthe end of the last wrap of the inner bandage. Subsequently the outerbandage 20 is applied, again typically suitably in a spiral techniquewith an appropriate overlap (suitably a standard 50% overlap) asexemplified in FIGS. 3 c-3 e. Typically the outer bandage 20 is appliedunder tension, preferably near or at full extension. For patients whocannot tolerate the desired therapeutic compressive force due to pain orover-sensitivity, it may be necessary or desirable to apply the outerbandage 20 with a lower degree of extension. In applications over areaof joints, e.g., over an ankle, a figure-of-eight configuration may beused in combination with a spiral technique to ensure complete coverage.Once in place, the outer bandage 20 advantageously holds the bandagingsystem in place for extended periods of time to provide a therapeuticeffect.

FIG. 4 illustrates an exemplary embodiment of the compression bandagingsystem wherein the system further includes non-elongated wound dressing30 over which inner skin facing, elongated, elastic bandage 10 isapplied.

The following examples further illustrate the practice of the presentinvention. The examples are not intended to limit the invention, whichis defined in the appended claims.

Test Methods

Stretch and Recovery-of-Stretch Testing Procedure

a. A stretch testing instrument consisting of the following is used: Aframe with a fixed clamp at the top (upper clamp); a separate clamp (orother means) for attaching a weight to the bottom of the test specimen(lower clamp); a scale to measure the span of bench marks on thespecimen graduated in units of 1 mm ( 1/24 inch) (or in units of percentof original gage length)±0.1% and a weight with an attached hook and amass of 1000 g. The total tensioning weight including the weight havinga mass of 1000 g and the lower clamp weighing 45 g is 1045 g.

b. Test specimen is allowed to condition at 23° C. and 50% relativehumidity for 24 hours. Testing is performed at 23° C. and 50% relativehumidity.

c. After conditioning, the test specimen is placed on a smooth flatsurface and allowed to relax for at least 2 minutes. Thereafter a testsample dimension of 50.8 by 304.8 mm (2 by 12 inches) with the longdirection parallel to test direction is prepared, e.g., by punchingusing a cutting template. (In particular, a template consisting ofprotruding cutting knives embedded in a wooden housing of about 290mm×90 mm×17 mm dimension was used for cutting the test specimens to therequired test sample dimension of 50.8 mm×304.8 mm. The template wasplaced in alignment on top of a conditioned, fully relaxed test specimenwith the protruding knives facing the test specimen, and the test samplewas cut by applying pressure (typically manually using a hammer) againstthe protruding knives opposing smooth wooden surface.)

d. After allowing the test sample to relax for at least 2 minutes, twobench marks of 127±1 mm (5 inch) apart are placed from the center of thetest sample.

e. The two transverse ends of the test sample are then folded over untiltheir outer edges are in line with the two bench marks. (By doing this,the ends of the test sample are reinforced and the long dimension isreduced from 304.8 mm (12 inches) down to 215.9 mm (8.5 inches) inlength.)

f. One (transverse) end of the test specimen is then clamped with theupper clamp to the frame such that the test sample hangs freely and suchthat the lower edge of the clamp is in exact alignment with the upperbench mark.

g. On the lower (transverse) end of the test sample and in verticalalignment to the upper clamp, the lower clamp is attached, such that theupper edge of the clamp is in exact alignment with the lower bench mark.Accordingly the original test length (OL) is the distance between thetwo bench marks, 127 mm. Directly thereafter, the attachment hook of the1000 g weight is inserted in an opening of the lower clamp, and thenslowly (over approximately 5 s) the weight is allowed to hang freelythereby exerting tension to the test sample.

h. Using the scale, the distance between the bench marks is measured tothe nearest 0.5 mm (or to the nearest 1% of original gage length), afterthe freely suspending the weight for 60±2 sec. The measured distance isthe stretch length SL.

i. Directly thereafter, the weight and lower clamp are removed and thetest sample is allowed to recover without tension.

j. Using the scale, the distance between the bench marks is measured tothe nearest 0.5 mm (or to the nearest 1% of original gage length), afterthe tension has been removed for 120±4 sec. The measured distance is therecovery length RL.

k. Percent Stretch and Percent Recovery-of-Stretch are calculated asfollows:% Stretch=100×(SL−OL)/OL% Recovery-of-Stretch=100×(SL−RL)/(SL−OL)

l. 6 test samples are tested for each test specimen and the mean valuesfor % stretch and % recovery-of-stretch are calculated.

Water Vapor Transmission Rate (WVTR)

WVTR is measured in accordance with ASTM E 398-03 using a WaterPermeability Tester L80-5000 (available from Lyssy AG, 8702 Zollikon,Switzerland), wherein the conditions of the wet (high humidity) chamberare 37.8° C. and 100% relative humidity and the conditions of the dry(low humidity) chamber are 37.8° C. and 10% relative humidity.

For measurements of inner bandage samples, the foam layer faced the wet(high humidity) chamber while then the elastic substrate was facing theopposing dry (low humidity) chamber.

If a material to be tested has any bias from one face to the other face,the face of the material that is to be facing towards the skin of thepatient should be oriented towards the wet chamber.

Saline Absorbency Test

a. A dry 5.1 cm by 5.1 cm sample (2 inch by 2 inch) is weighed to obtaindry weight (DW).

b. Directly thereafter, the sample is immersed in phosphate-bufferedsaline (Sigma-Aldrich Chemical Co., Milwaukee, Wis.; dry powder blenddissolved in water to 0.9% NaCl) for thirty minutes at 37° C.

c. Upon removal, the sample is allowed to drip freely for thirtyseconds, and re-weighed to obtain wet weight (WW).

d. Percent absorbency of the sample is determined using the formula:% Absorbency=((WW−DW)/(DW))×100.

e. Three replications are performed with the reported result being themean value.

Saline Swelling Test

a. The width (dW), length (dL), and thickness (dT) of an approximate 5.1cm by 5.1 cm (2 inches by 2 inches) dry sample are measured using ascale graduated in units of 0.5 mm ( 1/48 inch).

b. Directly thereafter, the sample is immersed in phosphate-bufferedsaline (Sigma-Aldrich Chemical Co., Milwaukee, Wis.; dry powder blenddissolved in water to 0.9% NaCl) for thirty minutes at 37° C.

c. Upon removal, the sample is allowed to drip freely for thirtyseconds, and all three dimensions of the sample were immediatelyre-measured to obtain “wet” width (wW), length (wL) and thickness (wT).

d. Percent swelling of the sample is determined using the formula:% Swelling=[((wW*wL*wT)−(dW*dL*dT))/(dW*dL*dT)]×100.

e. Three replications are performed with the reported result being themean value.

Sub-Bandage Pressure Measurement

Sub-bandage pressure is monitored using three pressure transducers tapedto the skin of a leg of a healthy person (at rest and walking) under theapplied compression bandage system. The procedure is based on theprocedure described by Melhuish et al, in “Evaluation of Compressionunder an Elastic Tubular Bandage Utilised as an Introduction toCompression Therapy in the Treatment of Venous Leg Ulcers” Phlebology(2000) 15: 53-59.

a. Three strain gauge temperature-compensated (15-40° C.) pressuretransducers, each having a diameter of 13 mm and a thickness of 3 mm(available by Gaeltec Ltd., Dunvegan, Isle of Skye, Scotland IV55 8GU)are used.

b. Before measurement, instrumentation is allowed a settling time of atleast 5 minutes, and the pressure transducers are calibrated in an airchamber against a sphygmomanometer (available by Gaeltec Ltd., Dunvegan,Isle of Skye, Scotland IV55 8GU).

c. The transducers (typically connected via amplifiers and filters to acomputer for data storage and analysis) are then placed on the lateralaspect of the non-dominant leg (of the test person) in line with themedial malleolus positioned as follows:

-   -   Sensor 1: at 8 cm above the lateral malleolus (i.e.        approximately at the origin of the Achilles tendon);    -   Sensor 3: at 5 cm below the caput fibulae; and    -   Sensor 2: at a position located exactly at the midpoint between        the positions Sensors 1 and 3.

The sensors are fixed into positioned by taping down their connectingwires with one or two small pieces of tape; the transducer itself is notcovered with tape.

d. The compression bandage system is applied (typically by anexperienced nurse).

e. For measurement of sub-bandage resting pressures - pressuremeasurements are taken over a 5-minute period (typically with 20measurement readings per second) with the test person sitting in anupright position with his legs extending horizontally and beingsupported from underneath. From this measurement set, a selection of aset of consecutive, steady (i.e., no statistically significant stepchanges in measured pressure readings) pressure readings over a periodof at least one minute is made, and the mean value of said pressurereadings is determined and reported in mm Hg. (The aforesaid selectionis made to exclude significant changes in pressure readings resultinge.g., from movement of the test person. If no set of consecutive,relatively steady pressure readings over a period of at least one minuteis observed, the measurement is repeated.)

f. For measurement of sub-bandage walking pressures—pressuremeasurements are taken over a 5-minute period (typically with 20measurement readings per second) with the test person walking on atreadmill at no incline and at a velocity of 2.5 km/h. From thismeasurement set, a selection of a set of consecutive, steady (i.e., nostatistically significant step changes in measured pressure readings)pressure readings over a period of at least one minute is made, and themean value of said pressure readings is determined and reported in mmHg. (The aforesaid selection is made to exclude statisticallysignificant step changes in pressure measurement resulting e.g., fromchanges in walking speed, stumbling, etc. of the test person. If no setof consecutive, steady pressure readings over a period of at least oneminute is observed, the measurement is repeated.)

Slippage Measurement

After a compression bandage system is applied to the leg of a healthytest person, a marker line is placed directly above the upper edge ofthe applied compression bandage system. Downward slippage (DS) is thendetermined, as the difference (measured by means of a scale graduated inunits of 1 mm (±0.1 %)) between the height of the upper edge ofinitially applied bandage system (initial height IH) and the height ofthe upper edge of the applied bandage system after 24 h of wear (heightafterwards HA), DS=IH−HA. Results are reported in cm.

Examples

Preparation of Self-Adhering Compression Bandages for Use as an OuterBandage

Self-adhering elastomeric bandages that do not adhere to clothing, hairor skin were prepared according to the process described in U.S. Pat.No. 4,984,584. In particular two thin dry-laid acrylic-binder-bondednonwoven PET (1.5 denier) fibrous webs, each having a basis weight of 11g/m², were brought into contact with 560 denier Spandex elastic yarns,longitudinally aligned and spaced apart (either 10, 14 or 20 epi) andpartially extended (the draw ratio (ratio of stretched length to relaxedlength of yarn) being selected to be either about 1.5:1 or 1.75:1) toprovide a composite construction with the yarns between the two nonwovenwebs, which was subsequently impregnated (coating weights between 31 and52 g/m²) with a latex based fluid binder mixture including 69% (based onfluid weight) of an aqueous anionic colloidal dispersion of 2,3dichloro-1,3-butadiene and chloroprene copolymer (about 50% solids, 40%chlorine, Brookfield viscosity (spindle 1, 6 & 30 rpm) at 25° C. 10 cps)and 31% (based on fluid weight) of an aqueous dispersion of aromaticmodified hydrocarbon resin having a ring and ball softening point ofabout 70° C. (about 55% solids, Brookfield viscosity at 25° C. 1,000cps) plus relative to 100 parts of copolymer 4 parts of zinc oxide, 2parts antioxidant, 0.5 parts pigment and 0.16 parts of a defoamer. Afterdrying, the resulting sheet material was slit into bandages 10 cm wideand between 2 to 2.5 meters long (unstretched dimensions).

The following table summarized the prepared self-adhering compressionbandages for use as outer bandages:

TABLE 1 Relaxed Coating basis % WVTR Desig- Draw weight weight % Recov-(g/m²/ nation epi ratio (g/m²) (g/m²) Stretch* ery* 24 h) O1 10  ~1.5:131 130 50 98 3470 O2 14  ~1.5:1 45 140 37 98 3608 O3 14 ~1.75:1 52 16252 97 — O4 20 ~1.75:1 45 173 55 98 — *in the longitudinal directionPreparation of Elastic Substrate/Foam Laminates for Use as an InnerBandage

As elastic substrate, in each case, a self-adherent elastomeric webmaterial (having dimensions of 10 cm by 2 m) that does not adhere toclothing, hair or skin was used. Similar to the outer bandage, the sheetmaterial for the elastic substrate was prepared according to the processdescribed in U.S. Pat. No. 4,984,584 using 280 denier Spandex yarns at10 epi between two nonwoven webs as described above with a draw ratio ofabout 3.5:1 and impregnating (coating weight of 52 g/m²) with a latexbased fluid binder mixture as described above. After drying, theresulting sheet material (having a relaxed basis weight of 179 g/m²) wasslit into strips of 10 cm wide and 2 meters long (unstretcheddimensions) for use as elastic substrate. The elastic substrate showed astretch capability in the longitudinal direction of 110% and arecovery-of-stretch capability in the longitudinal direction of 98%; andis referred to in the following as ES.

Four different polyurethane foams were used as follows:

A hydrophobic polyurethane foam available from THE WOODBRIDGE GROUP(Mississauga, Ontario, Canada) under the trade designation BIOFREE SM25; referred to in the following as F1. F1 had a thickness of 4 mm, ameasured saline absorbency of 2969% and a saline swelling of 0.4%.

A hydrophobic polyurethane foam having hydrophilic characteristicsavailable from Fulflex, Inc (Middelton, R.I., USA) under tradedesignation POLYCRIL 400; referred to in the following as F2. F2 had athickness of 4 mm, a measured saline absorbency of 1089% and a salineswelling of 8%.

A hydrophilic polyurethane foam available from Fulflex, Inc (Middelton,R.I., USA) under trade designation POLYCRIL 300; referred to in thefollowing as F3. F3 had a thickness of 3 mm, a measured salineabsorbency of 560% and a saline swelling of 8%.

A hydrophilic polyurethane foam available from Corpura B.V. (Etten-Leur,Netherlands) under the trade designation VIVO MFC.03; referred to in thefollowing as F4. F4 had a thickness of 3 mm, a measured salineabsorbency of 1805% and a saline swelling of 26%.

In manually preparing the foam-elastic substrate laminates, acrylicadhesive based transfer adhesive strips (thickness 76.2 μm, width of 16and/or 28 cm) were applied extending lengthwise across the width(starting from the two longitudinal edges working towards the center) ofa face of elongated foam layer sheet having outer dimensions of 31 to 49cm by 2 to 2.5 m for F1 to F4. Slight pressure was applied by hand,establishing a first contact between adhesive and foam, and to furtherenhance good contact, the transfer adhesive was then manuallyrolled-over with a rubber hand roller over its release liner, rollingtwo to three times over the entire length and width of the foam-adhesivecomposite. After removing the release liner of the foam-adhesivecomposite, a face of a relaxed elastic substrate (dimensions 10 cm by 2m) was placed over the exposed face of the transfer adhesive. Dependingon the particular width of the foam layer sheet, this step was repeatedwith two or three additional relaxed elastic substrates. (Previous tostep of application to the adhesive, each elastic substrate was placedflat on a smooth surface and allowed to relax completely for at least 2minutes.) To ensure good contact between the elastic substrate(s) andthe adhesive, the composite was turned over and the foam side wasmanually rolled-over with a rubber hand roller. The resulting compositewas cut to width and in length by removing around 5 mm at bothtransverse ends (both relative to the width and length of the elasticsubstrate(s)) to yield inner bandages having relaxed dimensions of 10 cmand around 1.9 m, with the foam layer being co-extensive with theelastic substrate. The bandages were then wound on cores having an innerdiameter of 30mm for later use as inner bandage.

The following table summarized the prepared elastic substrate/foamlaminates:

TABLE 2 Designation WVTR (g/m²/24 h) % Stretch* % Recovery* ES-F1 740 3997 ES-F2 799 45 96 ES-F3 401 38 96 ES-F4 806 69 98 *in the longitudinaldirectionExemplary Compression Bandaging Systems

Exemplary bandaging systems using outer bandages (Table 1) inconjunction with inner bandages (Table 2) as listed in the followingtable were used in testing (summarized below) on legs of healthy, inhouse volunteers.

TABLE 3 Example No. Outer Bandage Inner Bandage 1 O1 ES-F2 2 O2 ES-F2 3O3 ES-F2 4 O4 ES-F2 5 O2 ES-F1 6 O2 ES-F3 7 O2 ES-F4 C1 4 layercompression wrap

Also a four layer compression bandage commercially available under thetrade designation PROFORE (18-25 cm ankle pack) from Smith & NephewMedical Ltd. (Hull HU3 2BN, England) was used as a comparative example,C1. This bandage consists of an inner layer of orthopedic wool (apolyester-based “wool”), a second layer crepe bandage, a third layer oflight compression bandage and a fourth layer of self-adherent flexiblebandage.

Method of Applying Exemplary Compression Bandaging Systems

The inner bandage with foam layer facing towards and contacting the skinwas wound onto the lower leg without any tension in a simple (ascending)spiral technique using about a 10% overlap, starting at the base of thetoes and ending just below the fibular head. After cutting any excessbandage length, the applied inner bandage was then temporarily securedat the end of the last wrap with a small piece of medical tape, such as3M MICROPORE (available by 3M Company, St. Paul, USA). Subsequently, theouter bandage was applied at full stretch starting at the base of thetoes using two spiral turns to secure the bandage and then twofigure-of-eight turns around the ankle joint (to ensure the heel wascompletely covered). Application was continued then in a simple(ascending) spiral technique with a 50% overlap ending just below thefibular head and if necessary cutting off any excess length of thebandage.

Method of Applying Comparative Four Layer Compression Bandage

Application was carried out in accordance with the instruction ofmanufacturer. First the inner layer was applied from the base of thetoes to the knee using a simple (ascending) spiral technique with 50%overlap. Any excess material was cut off and the end was secured with apiece of tape. In the next step, the second layer was applied from thebase of the toes to the knee over the inner bandage (a slight border ofthe inner layer was allowed to remain visible) using a simple spiraltechnique, applying at mid-stretch and 50% overlap. Any excess materialwas cut off and the end of the second layer was secured with piece oftape. The third layer was then applied, starting at the base of the toesup to the knee, using a figure-of-eight technique at 50% extension ofthe bandage. The end of the bandage was then secured with a piece oftape. Then the fourth layer was applied starting from the toes to theknee using a spiral technique with 50% overlap and 50% extension.Following the application of the fourth layer, the cohesive bandage, thesurface was lightly pressed by hand to ensure sufficient cohesion of thebandage to itself.

For all testing, all bandages were applied by an experienced nurse.

After application, the exemplary bandaging systems in accordance withthe invention described herein are considerably thinner than thatobserved for the comparative bandaging system. The comparative bandagesystem had an applied thickness of 6.03 mm, while for example thebandaging system of Examples 2, 5 and 7 had an applied thickness of2.90, 1.87 and 3.25 mm, respectively (as measured using a digital slidegauge (available by Preisser Messtechnik GmbH & Co.KG, 72501Gammertingen, Germany). Also advantageously, the exemplary bandagingsystems in accordance with the invention described herein have anapplied thickness considerably thinner than the sum of the thicknessesof their individual outer and inner bandages. For example, in thebandaging system of Example 2 including an outer bandage (O1) having athickness of 0.89 mm and an inner bandage (ES-F2) having a thickness of5.38 mm, the applied thickness was 2.90 mm.

First Series of Sub-Bandage Pressure Testing

Four sets of 12 in-house, healthy volunteers were used for four sets ofcomparative testing of sub-bandage pressure. Compression bandagingsystems of Examples 1 to 4 were each compared to comparative C1. In alltesting—measuring pressures at rest and during walking in accordance tothe sub-bandage pressure measurement procedure detailed above—thecompression bandage system was applied to the non-dominant leg of thevolunteer. The same volunteer was used with the testing of one ofExamples 1 to 4 and in each case C1 in sequence. After testing onesystem, it was removed, leaving the three pressure transducers untouchedin their secured positions. The pressure transducers were re-zeroedappropriately. The second bandage was applied and pressure measurementswere made. The means for the sub-bandage pressure measurement resultsfor all 12 volunteers were computed and are reported in Table 4.

TABLE 4 Sensor 1 Sensor 2 Sensor 3 Sensor 1 Sensor 2 Sensor 3 ExampleRest Rest Rest Walk Walk Walk No. (mmHg) (mmHg) (mmHg) (mmHg) (mmHg)(mmHg) 1 67.00 31.75 32.00 65.50 37.25 33.50 C1 57.75 36.50 35.75 59.0040.25 35.00 2 67.75 41.00 37.50 64.25 37.00 36.50 C1 50.00 37.50 36.5052.50 33.50 37.50 3 53.75 39.25 31.75 57.00 41.50 33.00 C1 47.00 37.5030.25 48.50 42.50 36.00 4 50.25 44.25 26.75 57.00 42.75 27.00 C1 44.2538.50 27.75 45.00 37.25 28.50Second Series of Sub-Bandage Pressure Testing

One set of 12 in-house, healthy volunteers were used for comparativetesting of sub-bandage pressure of compression bandaging systems ofExamples 2, 5, 6 and comparative C1 in sequence. As in the first seriesof sub-bandage pressure testing, the compression bandage system wasapplied to the non-dominant leg of the volunteer. As in the previoustesting, the first system was applied, tested, removed leaving thepressure transducers untouched in their in their secured positions,transducers re-zeroed, next system applied, tested, removed, etc. untilthe fourth system was applied and tested. The mean for the sub-bandagepressure measurement results for all 12 volunteers were computed and arereported in Table 5.

TABLE 5 Sensor 1 Sensor 2 Sensor 3 Sensor 1 Sensor 2 Sensor 3 ExampleRest Rest Rest Walk Walk Walk No. (mm Hg) (mm Hg) (mm Hg) (mm Hg) (mmHg) (mm Hg) 2 43.75 49.50 24.91 46.17 56.50 29.58 5 46.91 51.67 31.8348.0 57.33 37.50 6 51.33 61.33 36.83 55.92 69.58 42.58 C1 51.08 49.1731.25 54.17 55.67 39.50Slippage Measurements of Compression Bandage Systems

Four sets of 12 in-house, healthy volunteers were used for four sets ofcomparative testing of downward slippage after 24 h of wearing appliedbandage. Compression bandaging systems of Example 5, 6, 7 and C1 werecompared to each case to compression bandaging system of Example 2. Inorder to provide a direct comparison, the bandage system of Example 2was applied to one leg of the volunteer, and the second bandage system,Examples 5, 6, 7 or C1 respectively, was applied to the other leg. Themean for the slippage results for all 12 volunteers were computed andare reported in Table 6.

TABLE 6 Example No. Slippage after 24 h wear (cm) 2 0.32 5 0.41 2 0.34 60.50 2 0.48 7 0.81 2 0.38 C1 4.18

Various modifications and alterations to this invention will becomeapparent to those skilled in the art without departing from the scopeand spirit of this invention. It should be understood that thisinvention is not intended to be unduly limited by the illustrativeembodiments and examples set forth herein and that such examples andembodiments are presented by way of example only with the scope of theinvention intended to be limited only by the claims set forth herein asfollows.

1. A compression bandaging system comprising: a) an inner skin facing,elongated, elastic bandage having inner and outer faces and comprising:(i) an elongated, elastic substrate having first and second faces, thesecond face comprising a self-adhering material, and (ii) an elongatedlayer of foam, said foam layer being affixed to the first face of saidsubstrate and extending 33% or more across said first face of substratein transverse direction and 67% or more across said first face ofsubstrate in longitudinal direction, the foam layer having an exposedface not affixed to the first face of said substrate and not comprisinga self-adhering material, the inner face of the inner bandage comprisingthe exposed face of the foam layer, and the outer face of the innerbandage comprising the second face of the elongated, elastic substrate;and b) an outer, elongated, self-adhering elastic bandage; said bandagehaving a compressive force when extended; wherein, in use, said outerbandage overlies the inner bandage, and said inner face of the innerbandage faces the skin, and the outer face of the inner bandage facessaid outer bandage, wherein the inner and outer bandages are configuredand adapted such that in use said bandages remain adhered to one anotherunder elastic extension without the use of a fastening mechanism, andwherein the bandaging system is free of any additional elongatedbandages.
 2. A bandaging system according to claim 1, further comprisinga non-elongated wound dressing or plaster.
 3. A bandaging systemaccording to claim 1, wherein the outer bandage has a stretch capabilityof 75% at most in the longitudinal direction.
 4. A bandaging systemaccording to claim 1, wherein the outer bandage has arecovery-of-stretch capability of at least 85% in the longitudinaldirection.
 5. A bandaging system according to claim 1, wherein the outerbandage does not adhere to clothing, hair or skin.
 6. A bandaging systemaccording to claim 1, wherein the elastic substrate of the inner bandageis made of a material which is capable of exerting a compressive forcewhen extended.
 7. A bandaging system according to claim 1, wherein theinner bandage has a stretch capability of less than 75% in thelongitudinal direction.
 8. A bandaging system according to claim 1,wherein the inner bandage has a recovery-of-stretch capability of atleast 80% in the longitudinal direction.
 9. A bandaging system accordingto claim 1, wherein the foam layer extends 80% or more across the faceof the substrate in the longitudinal direction.
 10. A bandaging systemaccording to claim 1, wherein the foam layer extends 50% or more acrossthe face of the substrate in the transverse direction.
 11. A bandagingsystem according to claim 1, wherein the foam layer has a thicknessgreater than 1.6 mm.
 12. A compression bandaging system comprising: a)an inner skin facing, elongated, elastic bandage having inner and outerfaces and comprising: (i) an elongated, elastic substrate having firstand second faces, the second face comprising a self-adhering material,and (ii) an elongated layer of foam, said foam layer being affixed tothe first face of said substrate and extending 33% or more across saidfirst face of substrate in transverse direction and 67% or more acrosssaid first face of substrate in longitudinal direction, the foam layerhaving an exposed face not affixed to the first face of said substrateand not comprising a self-adhering material, the inner face of the innerbandage comprising the exposed face of the foam layer, and the outerface of the inner bandage comprising the second face of the elongated,elastic substrate; and b) an outer, elongated, self-adhering elasticbandage; said bandage having a compressive force when extended; wherein,in use, said outer bandage overlies the inner bandage, and said innerface of the inner bandage faces the skin, and the outer face of theinner bandage faces said outer bandage, wherein the inner and outerbandages are configured and adapted such that in use said bandagesremain adhered to one another under elastic extension without the use ofa fastening mechanism, and wherein the bandaging system is free of anyadditional elongated bandages, and the inner bandage when extendedprovides less compression than the outer bandage when extended.